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Preoperative Fasting vs. Not Fasting in Critically Ill Patients

This study is looking at whether critically ill patients who are on a breathing machine and receiving tube feeding should fast (stop tube feeding 8 hours before) or not fast (continue tube feeding until surgery) before a planned surgery or procedure. The goal is to see if one approach is safer and leads to better recovery. Researchers want to know if there's a difference in lung complications, how long you stay on a breathing machine, recovery times, hospital stays, infection rates, and overall nutrition. This study aims to enroll up to 1072 participants aged 18 or older who are currently in the ICU with a secure airway and receiving tube feeding. The main way they will measure success is by looking at how many days you are alive and free from mechanical ventilation 28 days after your procedure. The current status of this study is unclear.

Study design
This is a randomized study where participants will be assigned to either the fasting or not fasting group. It plans to include up to 1072 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your health will be monitored for at least 28 days after your procedure to see how many days you are alive and free from mechanical ventilation.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06751043

Preoperative Fasting vs. Not Fasting in Critically Ill Patients

Recruiting
NAAges 18+InterventionalPrevention
Massachusetts General Hospital
~1,072 participants
Updated 2026-06-12 on ClinicalTrials.gov
What's tested:FastingNot fasting

At a glance

Recruiting sites
13 of 19 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Days alive and free from mechanical ventilation on postoperative day 28.
Measured over Post-operative day 28

Conditions

Critical Illness
Surgical Procedure, Unspecified
Pulmonary Aspiration
Fasting

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Critical Illness

Where it's being run

19 sites across 11 states
New York4
Massachusetts3
California2
Illinois2
Texas2
Colorado1
Florida1
Maryland1

Study leadership

  • Alexander Nagrebetsky, MD, MSC · PRINCIPAL_INVESTIGATOR · Massachusetts General Hospital

Who to contact

Alexander Nagrebetsky, MD, MSC
[email protected]
617-724-3292
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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Do NOT have a well-established practice of preoperative fasting. (For example, bedside placement of a vascular catheter \[arterial, central venous, peripheral venous\] by the ICU team is NOT eligible for this trial since it has a widely established practice of no preoperative fasting and is not generally scheduled for a specific time.)
Do NOT require fasting for preoperative gastrointestinal tract preparation
Do NOT require removal/replacement of the endotracheal or tracheostomy tube
Do NOT require prone or Trendelenburg (head-down) positioning.
Typically require procedural sedation or anesthesia care.
Generally, are scheduled for a specific time (although this time can change, or procedure may be cancelled).
Are performed in the operating room, non-operating room procedural areas, or at the patient's bedside.
All ICU types are eligible: surgical, medical, cardiac, neurological, trauma, mixed etc.
Secure airway is defined as a cuffed endotracheal tube or a cuffed tracheostomy tube.
Patients with all types of feeding tubes are eligible, regardless of tube insertion site (nasal, oral, surgically implanted) and tube tip location (pre- and post-pyloric) †As determined by the enrolling physician-investigator

What this trial measures

  • Days alive and free from mechanical ventilation on postoperative day 28.Post-operative day 28

    Defined as the days alive and free of organ support (dialysis, assisted ventilation, and vasopressors) to day 28. Participants will need to be free of all three components (assisted ventilation, vasopressors, new renal replacement therapy) to qualify for a day alive and free from organ failures. Patients on chronic dialysis will not be scored for the new renal failure free component of this outcome.